MAUDE Adverse Event Report: ST. JUDE MEDICAL MAXIMUM HEMOSTASIS INTRODUCER; INTRODUCER, CATHETER

Model Number	406253
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product evaluation: the reported event of a leak could not be confirmed.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.The maximum introducer instructions for use (ifu) states that damage to the valve assembly may occur if inner catheter is withdrawn rapidly.
Event or Problem Description
When using the 8f maximum hemostasis introducer the hemodynamic valve was leaky.A non-abbott device was used to complete the procedure.Patient's information (e.G.Age, weight, gender, patient's initials) cannot be handled by abbott in absence of patient's written consent as required by the personal data protection national legislation.National legislation prevents the recording of such information.A written consent has not been obtained in this case; therefore, this information is not available.

• Brand Name: MAXIMUM HEMOSTASIS INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 7688121
• Report Number: 3005334138-2018-00205
• Device Sequence Number: 1398349
• Product Code: DYB
• UDI-Device Identifier: 05414734008402
• UDI-Public: 05414734008402
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K870374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 406253
• Device Catalogue Number: 406253
• Device Lot Number: 6371274
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 07/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention